Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2025-12-24 @ 10:44 PM
NCT ID:
NCT01754935
Eligibility Criteria:
Inclusion Criteria:
* Male and female subjects 18 to 65 years of age (inclusive)
* Diagnosis of RA
* Swollen joint count of ≥6 out of 66 joints and tender joint count of ≥6 out of 68 joints
* Seropositivity based on either a positive rheumatoid factor or anti cyclic citrullinated peptide antibody at screening -OR- known erosive disease based on previous X-ray report or erosions detected on screening hand and foot X-ray
* Baseline CRP level or Westergren erythrocyte sedimentation rate ≥1.2 × upper limit of normal
* Receiving stable therapy with 1 of the following DMARDs: methotrexate, sulfasalazine, leflunomide, anti-malarial drug, or penicillamine
* Palpable 2+ synovitis of the wrist or ≥2 MCPs in the MRI-designated hand
Exclusion Criteria:
* History or presence of a clinically significant medical disorder other than RA that, in the opinion of the investigator and medical monitor, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
* Inflammatory, rheumatological disorders other than RA, where arthritis may be a prominent feature
* Planned surgery during the study
* History of alcohol or drug abuse, or excessive alcohol consumption
* History of tuberculosis (TB) infection of any kind (pulmonary or extrapulmonary, active or latent), regardless of history of anti-TB treatment.
* Pregnant or nursing an infant or with a life partner who is pregnant, nursing, or planning to become pregnant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01754935
Study Brief:
Protocol Section:
NCT01754935